Phase 4 Macular Degeneration Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with a form of wet age-related macular degeneration (AMD) called neovascular AMD (nAMD), where abnormal blood vessels affect the central part of the retina (the macula)
• People whose two eyes have a similar level of a specific cell count in the cornea (the clear front layer of the eye), with less than 10% difference between eyes, as measured by a special eye exam
• People for whom historical records of eye test results (including vision measurements and retinal scans) are available
• People for whom complete records of all previous anti-VEGF eye injection treatments — including which medicine was used and when — are available from the time of diagnosis, or for at least the 2 years before joining the trial
• People whose nAMD showed a response to at least two previous anti-VEGF eye injections, based on reduced disease activity on retinal scans and stable or improved vision
• People with a vision level of at least 34 letters on a standard eye chart (roughly equivalent to 20/200 on a Snellen chart) at the time of screening and enrollment
• People whose nAMD lesions involve the central area of the retina (the macula)
• People who have sufficiently clear eyes to allow retinal imaging and examination

Who may not be able to join:

• People who have previously had radiation therapy or a heat-based laser treatment (transpupillary thermotherapy) directed at the eye being studied
• People who received a light-activated injection treatment (photodynamic therapy/PDT) or steroid injections into the eye within the past 2 years
• People who have had laser treatment for AMD in the eye being studied (other than PDT)
• People who have had a corneal transplant (including partial-thickness grafts) in either eye
• People who have had surgery on the conjunctiva (the tissue covering the white of the eye) in a specific region of the eye being studied (the upper outer area)
• People who have had inflammation inside the eye after a previous anti-VEGF injection
• People who have previously had a port delivery system (PDS) implant placed in either eye
• People who have had any eye surgery, including cataract surgery, within 6 months of joining the trial
• People who have previously had surgery inside the eye to treat AMD, or surgery to remove the fluid-like substance inside the eye (vitrectomy)
• People who have previously had a device implanted inside the eye (other than an artificial lens)
• People who have had glaucoma surgery or similar procedures in either eye
• People who have previously taken part in a clinical trial involving eye injections of medicines not yet approved at the time of screening
• People who have had certain types of eye laser treatments within the past year, or a specific laser procedure (YAG capsulotomy) within the past 3 months
• People who have worn contact lenses in either eye within the past 2 months
• People who have had a penetrating eye injury at any time
• People who have had a blunt eye injury that affected the health of the cornea or retina, or any blunt eye injury within 6 months of screening
• People who have previously been treated with a medicine called brolucizumab
• People who have a known allergy or sensitivity to ranibizumab or any of the ingredients in the study medicine (Susvimo)
• People who have bleeding under the central part of the retina (fovea) larger than a set size in the study eye
• People who have scarring or tissue loss under the central retina in the study eye
• People whose AMD-like condition is caused by something other than age-related macular degeneration (such as an eye infection, injury, or severe short-sightedness)
• People whose condition looks like AMD on imaging but is actually a different eye disorder
• People with a tear in the retinal pigment layer of the study eye
• People with untreated retinal tears, or tears treated within the past 3 months, in the study eye
• People with active bleeding into the gel-like fluid of the study eye
• People with a current or past history of retinal detachment in the study eye
• People with high levels of short-sightedness (more than 8 diopters of myopia) or high levels of long-sightedness (more than 5 diopters of hyperopia) in the study eye
• People with uncontrolled high eye pressure or glaucoma in the study eye
• People with certain structural or tissue abnormalities in a specific region of either eye (the upper outer area of the eye surface or white of the eye)
• People with a history of severe or recurring eyelid conditions such as severe dry eye, repeated eyelid cysts, or severe eye allergies
• People with eyelid problems that affect the eyelid's ability to properly protect the eye surface
• People with eyelashes growing inward (trichiasis), reduced corneal sensation, inability to fully close the eye, or a history of facial nerve problems
• People with a corneal cell count at or below 1,500 cells per square millimetre in either eye at screening
• People with a moderate or severe form of a corneal condition called Fuchs endothelial corneal dystrophy (Grade 2 or higher)
• People with previous damage to the inner layer of the cornea from injury or surgery
• People with active or past corneal swelling, corneal disease, certain corneal-iris disorders, or a condition causing protein deposits around the eye (pseudoexfoliation syndrome)
• People with a current or past history of herpes-related eye infection, uveitis (eye inflammation), or inflammation inside the eye
• People with active or past infections or inflammation of the cornea, the white of the eye, or the inside of the eye
• People with active eye or surrounding tissue infection
• People with active or past Sjögren's syndrome, floppy eyelid syndrome, chronic eye rubbing, or active thyroid eye disease
• People with a history of uncontrolled high blood pressure
• People with active or past autoimmune conditions such as rheumatoid arthritis, lupus, or Wegener's granulomatosis
• People who have had a stroke within the past 3 months
• People with uncontrolled irregular heart rhythm (atrial fibrillation) within the past 3 months
• People who have had a heart attack within the past 3 months
• People with other serious health conditions or laboratory results that, in the doctor's opinion, make the study treatment unsafe or unsuitable
• People with a current active infection anywhere in the body
• People currently using anti-VEGF medicines taken by mouth or injection into the body (systemic anti-VEGF agents)
• People who regularly take oral corticosteroid (steroid) medicines
• People with an active cancer diagnosis within the past 12 months (certain early-stage or low-risk cancers may be exceptions — confirm with trial site)
• People who have taken part in a non-eye-related clinical drug trial within the past month
• People who have used certain chemotherapy-type medicines within the past 30 days or within a set washout period before screening
• People who are pregnant, breastfeeding, or planning to become pregnant during the trial
• Women who could become pregnant and who do not have a negative pregnancy test result within 28 days before starting the study treatment

Important: Always verify eligibility with the trial site directly before applying.